双环醇片治疗药物性肝损伤疗效与安全性的系统评价

发布时间：2018-06-03 00:54

本文选题：双环醇片 + 药物性肝损伤　；参考：《中国药房》2015年09期

【摘要】：目的:系统评价双环醇片治疗药物性肝损伤(DILI)的有效性与安全性,以为临床治疗提供循证参考。方法:计算机检索Pub Med、Cochrane图书馆临床试验数据库、中国生物医学文献数据库、中文科技期刊数据库、相关期刊论文,收集双环醇片(试验组)对比其他药物(对照组)治疗DILI的随机对照试验(RCT),按照纳入与排除标准进行筛选,评价文献质量并采用Rev Man 5.2统计软件对数据进行Meta分析。结果:共纳入11项RCT,合计1 183例患者。Meta分析结果显示,试验组患者的总有效率显著高于对照组[OR=2.83,95%CI(1.59,5.03),P0.001],在改善患者丙氨酸氨基转移酶[MD=-28.10,95%CI(-34.42,-21.78),P0.001]、天冬氨酸氨基转移酶[MD=-15.30,95%CI(-20.77,-9.83),P0.001]、总胆红素[MD=-1.91,95%CI(-3.36,-0.46),P=0.01]等方面亦显著优于对照组。试验组患者不良反应发生率与对照组比较,差异无统计学意义[OR=0.45,95%CI(0.20,1.01),P0.001]。结论:双环醇片治疗DILI的疗效优于其他阳性药物,且安全性相似。但由于纳入研究存在高偏倚风险,该结论尚需高质量的RCT进一步验证。
[Abstract]:Objective: to evaluate the efficacy and safety of bicyclol tablets in the treatment of drug-induced liver injury. Methods: the database of clinical trials, Chinese biomedical literature, Chinese scientific and technological journals and full-text databases of Chinese journals were searched by computer in Pub Medbin Cochrane Library. Bicyclic alcohol tablets (test group) were collected for the randomized controlled trial of DILI treatment compared with other drugs (control group). According to the criteria of inclusion and exclusion, the literature quality was evaluated and the data were analyzed by Meta 5.2 statistical software. Results: a total of 11 RCTs were included. The total effective rate of the patients in the trial group was significantly higher than that in the control group [OR2.83C95CII 1.59 / 5.03P0.001], and was also superior to that of the control group in improving the alanine aminotransferase [MD-28.101095 CI-34.42C-21.78 P0.001], aspartate aminotransferase [MD-15.3095CI-20.77hu -9.83P0.001] and total bilirubin [MD-1.995CI-3.36- 0.46P0. 01]. The incidence of adverse reactions in the trial group was not significantly different from that in the control group [ORX 0.45 + 95%]. Conclusion: the efficacy of bicyclol tablets in the treatment of DILI is superior to that of other positive drugs, and the safety is similar. However, due to the high risk of bias in the study, this conclusion needs to be further verified by high quality RCT.
【作者单位】：首都医科大学附属北京妇产医院药剂科;
【基金】：国家科技支撑计划项目子课题(No.2013BAI06B04Y023019)
【分类号】：R575

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